HealthyNCT04626401
Forearm Immobilization, Metabolic Health, and Nutrition
A study testing Forearm immobilization in people with Healthy, run by University of Exeter at 1 site in United Kingdom.
Trial summary
The present study will investigate the impact of dietary branched chain amino acid restriction on muscle atrophy, insulin sensitivity and muscle protein synthesis following short-term forearm immobilization Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Forearm immobilization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Jun 2021to 10 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females 18-40 years of age
- Body mass index between 18.5 and 30 kg/m2
Who cannot join
- Smoking
- Any diagnosed metabolic impairment (e.g. type 1 or 2 diabetes)
- Any diagnosed cardiovascular disease
- Hypertension (≥140 mmHg systolic and/or ≥90 mmHg diastolic)
- Chronic use of any prescribed or over the counter pharmaceuticals (excluding oral contraceptives and contraceptive devices)
- Regular use of nutritional supplements
Show all 14Show fewer
- Currently involved in a structured progressive resistance training programme (>3 times per week)
- A personal or family history of thrombosis, epilepsy, seizures or schizophrenia
- Any previous motor disorders or disorders in muscle and/or lipid metabolism
- Known hypokalaemia
- Presence of an ulcer in the stomach or gut and/or strong history of indigestion
- Known severe kidney problems
- Pregnant or breastfeeding
- Unable to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Dietary Branched-chain Amino Acid (BCAA) Restriction on the Development of Insulin Resistance and Anabolic Resistance During Forearm Immobilization in Healthy, Young Volunteers.
The present study will investigate the impact of dietary branched chain amino acid restriction on muscle atrophy, insulin sensitivity and muscle protein synthesis following short-term forearm immobilization
Read the detailed description
Twenty-four healthy young volunteers will undergo 2 days of forearm immobilization in combination with either a branched chain amino acid restricted diet or a control diet. Before and after immobilization, they will receive a stable isotope tracer infusion (5.5 h) combined with repeated blood and muscle sampling under insulin clamp conditions, in order to measure insulin sensitivity and muscle protein synthesis in the fasted and fed state.
- Conditions
- Healthy
- Being tested
- Forearm immobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forearm immobilizationBehavioural
Two days of forearm immobilization
| Study group | Role | What they receive |
|---|---|---|
| Control diet during immobilisation | Placebo comparator | A 2 day controlled dietary intervention. Receives: Behavioral: Forearm immobilization |
| Branched chain amino acid restricted diet during immobilisation | Experimental | A 2 day branched chain amino acid restricted dietary intervention. Receives: Behavioral: Forearm immobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forearm glucose uptake
Insulin sensitivity, measured as forearm glucose uptake, under hyperinsulinaemic-euglycaemic conditions
Measured: Hyperinsulinaemic-euglycaemic clamps are performed before and immediately after 2 days of forearm immobilisation. Forearm glucose uptake is measured during the steady state period of the clamp.
Secondary outcomes (4)
Muscle protein synthesis rates
Muscle protein synthesis rates are measured using an intravenously infused stable isotope labelled amino acid tracer, combined with repeated blood and muscle tissue sampling.
Measured: During 3 hours of hyperinsulinaemic-euglycaemic clamped conditions before and after 2 days of immobilisation
Intramuscular BCAA concentration
Intramuscular BCAA concentration measured using mass spectrometry
Measured: Before and after 3 hours of hyperinsulinaemic-euglycaemic clamped conditions
BCAA concentrations between forearm arterialized venous and deep venous blood
Arterialized venous-deep venous forearm balance of BCAA, in the fasted state and during a hyperinsulinaemic-euglycaemic clamp
Measured: Fasted and during the steady-state phase of the insulin clamp (i.e. last 30 minutes)
Whole-body substrate oxidation
Whole-body substrate oxidation measured using indirect calorimetry
Measured: Hyperinsulinaemic-euglycaemic clamps are performed before and immediately after 2 days of forearm immobilisation. Whole-body substrate oxidation is measured before the commencement of, and during the steady state period of the clamp (last 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start24 Jun 2021
- Primary completion10 Jun 2022
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust
- Responsible party
- Sponsor
- Investigators
- Marlou Dirks, PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626401
- Sponsor's protocol ID
- 200617
- Status last verified
- Aug 2022
- First submitted
- 22 Oct 2020
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dietary Branched-chain Amino Acid (BCAA) Restriction on the Development of Insulin Resistance and Anabolic Resistance During Forearm Immobilization in Healthy, Young Volunteers.
- ClinicalTrials.gov ID
- NCT04626401
- Acronym / sponsor ID
- 200617
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- Wellcome Trust
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study will investigate the impact of dietary branched chain amino acid restriction on muscle atrophy, insulin sensitivity and muscle protein synthesis following short-term forearm immobilization
Detailed description
Twenty-four healthy young volunteers will undergo 2 days of forearm immobilization in combination with either a branched chain amino acid restricted diet or a control diet. Before and after immobilization, they will receive a stable isotope tracer infusion (5.5 h) combined with repeated blood and muscle sampling under insulin clamp conditions, in order to measure insulin sensitivity and muscle protein synthesis in the fasted and fed state.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control diet during immobilisation | Placebo comparator | Behavioral: Forearm immobilizationA 2 day controlled dietary intervention. |
| Branched chain amino acid restricted diet during immobilisation | Experimental | Behavioral: Forearm immobilizationA 2 day branched chain amino acid restricted dietary intervention. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Males and females 18-40 years of age
- Body mass index between 18.5 and 30 kg/m2
Key exclusion criteria (14 listed)
- Smoking
- Any diagnosed metabolic impairment (e.g. type 1 or 2 diabetes)
- Any diagnosed cardiovascular disease
- Hypertension (≥140 mmHg systolic and/or ≥90 mmHg diastolic)
- Chronic use of any prescribed or over the counter pharmaceuticals (excluding oral contraceptives and contraceptive devices)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forearm immobilizationTwo days of forearm immobilization | Behavioural | Branched chain amino acid restricted diet during immobilisation, Control diet during immobilisation |
Primary outcome
Forearm glucose uptake
Time frame: Hyperinsulinaemic-euglycaemic clamps are performed before and immediately after 2 days of forearm immobilisation. Forearm glucose uptake is measured during the steady state period of the clamp.
Insulin sensitivity, measured as forearm glucose uptake, under hyperinsulinaemic-euglycaemic conditions
4 secondary outcomes
Muscle protein synthesis rates
Time frame: During 3 hours of hyperinsulinaemic-euglycaemic clamped conditions before and after 2 days of immobilisation
Intramuscular BCAA concentration
Time frame: Before and after 3 hours of hyperinsulinaemic-euglycaemic clamped conditions
BCAA concentrations between forearm arterialized venous and deep venous blood
Time frame: Fasted and during the steady-state phase of the insulin clamp (i.e. last 30 minutes)
Whole-body substrate oxidation
Time frame: Hyperinsulinaemic-euglycaemic clamps are performed before and immediately after 2 days of forearm immobilisation. Whole-body substrate oxidation is measured before the commencement of, and during the steady state period of the clamp (last 30 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marlou Dirks, PhD principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forearm immobilization in people with Healthy, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forearm glucose uptake (time frame: Hyperinsulinaemic-euglycaemic clamps are performed before and immediately after 2 days of forearm immobilisation. Forearm glucose uptake is measured during the steady state period of the clamp.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.